International Multicenter Clinical Trials: Benefits and Challenges

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

25 April, 2018

An international multicenter clinical trial is a joint research effort that involves more than one clinical center, and more than one country to recruit and treat subjects. These studies are essential when a single site does not have the potential to enroll enough patients to meet the objectives of the research, which is common, for instance, in studies focusing on rare diseases.

Depending on the needs of each clinical protocol, multinational trials may have different dimensions and particularities.

International multisite trials are more complex and costly than smaller projects.

Large numbers of hospitals and patients, and their geographical distribution cause practical challenges including the need of effective communication, agile drug and material logistics, staff trainings, and timely data management.

dies performed in various countries require a strong, well organized infrastructure and communication channels to control daily trial activities, and to collect and evaluate data generated by each site.

Several clinical and technical teams –including CROs– must be coordinated to cover regulatory affairs, site activation, enrollment support, pharmacovigilance, and clinical monitoring in each hospital, among other tasks.

In addition, large trials normally include specialized procedures such as the collection and centralization of laboratory samples (e.g. blood tubes and tumor blocks) and radiological imaging (DICOM files). Thus, appropriate technological tools must be in place to collect, track, and process these elements.

Without doubt, international multicenter clinical trials imply challenges and demanding tasks with regard to study planning, execution, analysis, and follow-up.

Nevertheless, the advantages of quick recruitment and, above all, the development of novel treatments for patients in need of new therapeutic options, should motivate sponsors, investigators, and all the actors involved, to seek excellence in the development of these important studies.

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com